Drug Master Files for: KETOPROFEN

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KETOPROFEN Drug Master Files

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DMF No.	Status	Type	Submission Date	Holder	Subject
10045	I	II	1/13/1993	NORDIC SYNTHESIS AB	KETOPROFEN
11099	I	II	9/28/1994	SEPRACOR INC	(S)-KETOPROFEN
11486	I	II	5/12/1995	NAGASE FINE CHEMICALS LTD	S-KETOPROFEN
12020	I	II	6/25/1996	CHIREX LTD	KETOPROFEN
18148	I	II	2/21/2005	BIDACHEM SPA	KETOPROFEN
19457	A	II	5/23/2006	SOCIETA ITALIANA MEDICINALI SCANDICCI SIMS SRL	KETOPROFEN
>DMF No.	>Status	>Type	>Submission Date	>Holder	>Subject

Drug Master File Glossary

STATUS OF DMFS

A = Active. This means that the DMF was found acceptable for filing, administratively, and is up-to-date.
I = Inactive
N = Not an assigned number
P = DMF Pending Filing Review

TYPES OF DMFs

Type I Manufacturing Site, Facilities, Operating Procedures, and Personnel (no longer applicable)
Type II Drug Substance, Drug Substance Intermediate, and Material Used in Their Preparation, or Drug Product
Type III Packaging Material
Type IV Excipient, Colorant, Flavor, Essence, or Material Used in Their Preparation
Type V FDA Accepted Reference Information

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